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Stimulation for Perinatal Stroke Optimizing Recovery Trajectories (SPORT)

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ClinicalTrials.gov Identifier: NCT03216837
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
University of Alberta
Holland Bloorview Kids Rehabilitation Hospital
The Hospital for Sick Children
Information provided by (Responsible Party):
Adam Kirton, University of Calgary

Brief Summary:
Perinatal stroke causes lifelong neurological disability and most hemiparetic cerebral palsy (CP). With morbidity spanning diverse aspects of a child's life and lasting for decades, global impact is large, including 10000 Canadian children. With pathophysiology poorly understood and prevention strategies non-existent, the burden of hemiparetic CP will persist. Limited treatments lead to loss of hope for children and families, necessitating exploration of new therapies. The investigators have evidence that the investigators have a durable new treatment for perinatal stroke, combining non-invasive neurostimulation and child-centred intensive rehabilitation. Via the CHILD-BRIGHT SPOR national network, the investigators will execute a multicentre trial to prove this treatment can improve function in children with perinatal stroke and hemiparetic CP. Using novel advanced technologies not available elsewhere in the world, the investigators will explore how developmental plasticity determines function and response to neuromodulation therapy. This patient oriented effort will advance personalized, precision medicine in pediatric neurorehabilitation to improve outcomes for disabled children and their families.

Condition or disease Intervention/treatment Phase
Perinatal Stroke Hemiplegic Cerebral Palsy Device: Cathodal transcranial direct current stimulation Device: Sham transcranial direct current stimulation Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stimulation for Perinatal Stroke Optimizing Recovery Trajectories
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

Arm Intervention/treatment
Experimental: Cathodal Transcranial direct current stimulation
Cathodal tDCS
Device: Cathodal transcranial direct current stimulation
The primary intervention will be cathodal (inhibitory) tDCS over the contralesional M1. Soft, replaceable 25cm2 electrodes (Soterix, NYC) will be placed on clean, dry areas of the scalp. The cathode will be placed over the contralesional M1, precisely mapped for each patient using neuronavigated (Brainsight2, Rogue Research, Montreal QU) MRI-TMS co-registration over the hotspot for the contralateral first dorsal interosseous muscle. The current-controlled model stimulator (Soterix, NYC) will automatically ramp up slowly over 30 seconds to the treatment current of 1.0 milliamp. tDCS will be administered each day during the first 30 minutes of the daily 1:1 therapy sessions.
Other Name: tDCS

Sham Comparator: Sham Transcranial direct current stimulation
Sham
Device: Sham transcranial direct current stimulation
Soft, replaceable 25cm2 electrodes (Soterix, NYC) will be placed on clean, dry areas of the scalp. The cathode will be placed over the contralesional M1, precisely mapped for each patient using neuronavigated (Brainsight2, Rogue Research, Montreal QU) MRI-TMS co-registration over the hotspot for the contralateral first dorsal interosseous muscle.The current-controlled model stimulator (Soterix, NYC) will automatically ramp up slowly over 30 seconds to the treatment current of 1.0 milliamp and then ramp down over 30 seconds to 0 milliamps. Sham will be administered each day during the first 30 minutes of the daily 1:1 therapy sessions.
Other Name: Sham




Primary Outcome Measures :
  1. Change from baseline in Assisting Hand Assessment (AHA) at 1 week, 2 month and 6 month post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention ]
    This is the established standard for the objective quantification of bilateral hand function in children with hemiparetic CP141. This Rasch-built evaluation carries the strongest evidence of inter-rater, intra-rater, and test-retest reliabilities, test-validity, and responsiveness to change for bimanual tasks in hemiparetic CP children 8 within our age range. Sensitivity to change and excellent clinimetric properties have been established in multiple pediatric hemiparetic CP clinical trials. Our trained therapists have successfully executed >100 AHA measurements in our current trial124 with no limitations and robust data.

  2. Change from baseline in Canadian Occupational Performance Measure (COPM) at 1 week, 2 month and 6 month post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention ]
    Individualized, family-centered tool identifying child and family-perceived difficulties in self-care, productivity (school), and activities142. Such subjective measures are essential in hemiparetic CP trials. Validated for our ages and such trials, the COPM was a robust measure in our previous perinatal stroke trials (Figure 4). We have recently characterized how COPM goals are set in this population and their relationship to success (Haspels et al, unpublished).


Secondary Outcome Measures :
  1. Change from baseline in Children's Hand-use Experience Questionnaire (CHEQ) at 1 week, 2 month, and 6 month post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention ]
    The CHEQ was developed for children and adolescents with decreased function in one hand, for example hemiplegic CP, obstetric brachial plexus palsy (OBPP) and upper limb reduction deficiency, and for their parents. The questionnaire evaluates the experience of children and adolescents in using the affected hand or hand prostheses in activities where usually two hands are needed.

  2. Change from baseline in Mirror Movements at 1 week, 2 month and 6 month post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention ]
    Clinical mirror movements will be quantified on a scale of 0-5 using a validated scale in both directions (i.e. affected and unaffected hand). Patients perform three tasks with each hand; finger tap, finger sequence and open/close grasp.

  3. Change from baseline in Jebsen Taylor Test of Hand Function (JTTHF) at 1 week, 2 month and 6 month post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention ]
    The Jebsen Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living

  4. Change from baseline using the Box and blocks at 1 week, 2 month and 6 month post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention ]
    Box and blocks evaluates manual dexterity

  5. Change from baseline in the Quality of Life (QoL) assessment at 1 week, 2 month and 6 month post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention ]
    These tools will evaluate social and emotional well-being, participation, school activities, access to services, pain and feelings about disability, and family health.

  6. Change in CNS Vitals battery at 1 week, 2 month and 6 month post intervention [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 6 months post intervention ]
    Includes the Visual Memory, Stroop and Continuous performance tests. These subtests measure attention, executive functioning, response/decision speed and memory.

  7. Change from baseline in mean movements during regular daily activities measured by MotionWatch at 1 week, 2 month and 6 month post intervention. [ Time Frame: 48 hour ephochs at baseline, 1 week post, 2 months and 6 months post intervention. ]
    Participants will be fitted bilaterally with actiwatches (MotionWatch) to record mean movements every 2 seconds for 48 hour epochs of time (baseline, 1 week, 2 months, 6 months) as well as continuously during the 2 week intervention phase. A standard diary will record sleep/wake patterns and activities. Importantly, we will do this bilaterally (2 watches) to generate the primary outcome of an actigraphic asymmetry index (AAI) calculated between the affected and unaffected limbs.


Other Outcome Measures:
  1. Change from baseline using the Box and blocks each day of the trial [ Time Frame: Baseline, day 1, day 2, day3 , day 4, day5, day 6, day 7, day 8, day 9, day 10. ]
    Box and blocks evaluates manual dexterity

  2. Pre and post intervention Advanced Neuroimaging [ Time Frame: Baseline, 1 week and 6 months post intervention. ]
    Standardized 3T MR protocol will be applied including task fMRI (affected and unaffected hands), resting state fMRI (primary outcome is M1 laterality index), diffusion tensor imaging and bilateral M1 MR spectroscopy.

  3. Pre and post intervention robotic motor mapping [ Time Frame: Baseline, 1 week and 6 months post intervention. ]
    Using each subject's anatomical MRI and neuronavigation (Brainsight2), a 10x10 grid with 7mm spacing will be placed over M1. A recently developed rapid mapping protocol (4 stimulations per site) will obtain mean MEP values for each active site. The robot allows precise targeting with real-time motion correction and rapid mapping. The primary TMS outcome will be area-under-the-curve of customized heat maps of contralesional motor cortex. Multiple upper extremity muscles will be simultaneously mapped from both hemispheres including dedicated ipsilateral projections from the contralesional hemisphere. Primary outcomes are motor map area, volume, and center of gravity. Additional TMS measures will include corticospinal tract arrangement, motor thresholds, MEP latency, and cortical silent period. We have successfully demonstrated these methods in children with stroke.

  4. Pre and post intervention KINARM Robot: Sensorimotor function [ Time Frame: Baseline, 1 week and 6 months post intervention. ]
    The KINARM exoskeleton (Kinesiological Instrument for Normal and Altered Reaching Movement) modified for children will assess limb movements at the shoulder and elbow. A standardized, validated assessment of sensorimotor function will include three tasks: position sense via a position matching task, kinesthesia, and visually guided reaching. Primary outcomes will be position sense during a position-matching task and bilateral motor impairment using a visually guided reaching task. We have just installed a dedicated pediatric KINARM at the Alberta Children's Hospital where all Alberta subjects will attend.

  5. Stanford Expectations of Treatment Scale (SETS) [ Time Frame: Baseline ]
    Questionnaire asks about participants expectations of the treatment and how they think they will respond. 6 questions have a 7 point scale from strongly disagree to strongly agree. 3 questions have written answers

  6. Change from baseline in Child and Adolescent Social Support Scale from 1 week, 2 month and 6 months post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 6 months post intervention ]
    Questionnaire asks the participant to rate the support they receive from a parent, classmate, teacher or close friend on different scenarios. There are two parts, one looks at how often they get support (6 point scale from never to always) the other part is asking about how important is the support (3 point scale from not important to very important).

  7. Change from baseline in Loneliness and Dissatisfaction from 1 week, 2 month and 6 months post intervention. [ Time Frame: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 6 months post intervention ]
    Questionnaire asks the participant to rate how true the statements provided are to them. There is 9 questions each on a 5 point scale (not true at all to always true about me).

  8. Sensation severity and tolerability ranking measures [ Time Frame: Day 1, 5 and 10 of treatment. ]
    Adapted from a published safety consensus statements and child-friendly tolerability evaluations for non-invasive brain stimulation. Measures will capture the presence and severity of various sensations associated with tDCS including: itching, tingling, nausea, burning, headaches, light headedness and other sensations. Additionally participants will rank tDCS tolerability relative to 7 other common childhood experiences.



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical and MRI confirmed perinatal ischemic stroke (NAIS, APPIS, PVI)
  2. Symptomatic hemiparetic CP including parent/child perceived limitations in function
  3. Able to briefly lift light object off a surface (estimated House class 3-6).
  4. Term birth (> 36 weeks)

Exclusion Criteria:

  1. Other neurological disorder not related to perinatal stroke
  2. Multifocal stroke
  3. Sever hemiparesis (no voluntary contraction, MACS V)
  4. Sever spasticity (Modified Ashworth Scale >3)
  5. Severe delay or inability to comply with protocol
  6. Unstable epilepsy
  7. TMS or MRI contraindication
  8. Botox, orthopedic surgery, constraint, brain stimulation or other modulatory therapy in past 6 months prior to camp day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216837


Contacts
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Contact: Jacquie Hodge, MSc 403-955-7733 jacquie.hodge@ahs.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2M 1N4
Contact: Adam Kirton, MD       adam.kirton@ahs.ca   
Principal Investigator: Adam Kirton, MD         
Sub-Investigator: John Anderson, MD         
Sub-Investigator: Darcy Fehlings, MD         
Sub-Investigator: Nomazulu Dlamini, MD         
Sponsors and Collaborators
University of Calgary
University of Alberta
Holland Bloorview Kids Rehabilitation Hospital
The Hospital for Sick Children
Investigators
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Principal Investigator: Adam Kirton, MD University of Calgary

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Responsible Party: Adam Kirton, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03216837     History of Changes
Other Study ID Numbers: REB16-2535
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adam Kirton, University of Calgary:
Perinatal stroke
hemiplegia
hemiplegic cerebral palsy

Additional relevant MeSH terms:
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Stroke
Cerebral Palsy
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Damage, Chronic